CoxarthrosisESPB_HIPNCT06282666
Lumbar ESPB in Hip Replacement Surgery
A study testing Spinal anesthesia, lumbar erector spinae plane block and Epidural analgesia in people with Coxarthrosis and Pain, Postoperative, run by Medical University of Lublin at 1 site in Poland.
Trial summary
In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coxarthrosis, Pain, Postoperative, Pain, Acute
- What is being tested?
- Spinal anesthesia, lumbar erector spinae plane block and Epidural analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 19 Feb 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary hip replacement surgery due to coxarthrosis
- anesthetized with spinal technique
- able to use PCA pump
- having access to phone
Who cannot join
- patients taking painkillers not related to coxarthrosis;
- having active cancer,
- dementia or challenging contact with the patient;
- suffering from depression or other psychiatric disorders that required antidepressant treatment;
- consuming alcohol or recreational drug addiction;
- contraindications to the regional block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Continuous Lumbar Erector Spinae Plane Block to Continuous Epidural Analgesia in Patients Undergoing Hip Replacement Surgery
In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed.
Read the detailed description
This is a prospective trial in patients undergoing elective hip replacement surgery.
Written informed consent will be obtained from each patient, and our study will be conducted following the tenets of the Declaration of Helsinki for medical research involving human subjects.
Before the surgery, preoperative pain severity, chronic pain severity, and ability to sit, stand, and walk will be assessed.
Each participant will be anesthetized with spinal technique and randomly allocated patients according to postoperative analgesia to the continuous epidural (Epidural) group and the continuous lumbar erector spinae plane block (ESPB) group. Both regional techniques will be continued during the first day. Investigators will measure postoperative oxycodone consumption with a patient-controlled analgesia (PCA) pump. At several points, the patients' pain at rest and during activity will be evaluated on the visual analog scale (VAS, 0-10), their quadriceps femoris muscle strength on the Lovett scale (0-5), and their ability to sit, stand upright, and walk on the Timed Up and Go test. Moreover, the patient's recovery will be assessed through the Quality of Recovery 40 (QoR-40) questionnaire on the first postoperative day.
After the patient's discharge, information regarding acute and chronic pain severity and quality of recovery will be collected during the phone interview.
- Conditions
- Coxarthrosis, Pain, Postoperative, Pain, Acute, Pain, Chronic, Postoperative Pain, Chronic, Analgesia
- Being tested
- Spinal anesthesia, lumbar erector spinae plane block, Epidural analgesia, patient-controlled analgesia, Timed Up and Go test
- Keywords
- erector spinae plane block, epidural analgesia, quality of recovery, patient-controlled analgesia, Timed Up and Go test, visual analog scale, neuropathic pain symptom inventory, Lovett scale, spinal anesthesia
- Medical subject headings
- Osteoarthritis, Hip, Pain, Postoperative, Acute Pain, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
Also called Subarachnoid anesthesia
Before the beginning of surgery, all patients will be anesthetized with 0.5 % hyperbaric bupivacaine (Marcaine Heavy), 1.5 - 2.5 mL solution. A pencil point spinal needle will be used.
lumbar erector spinae plane blockProcedure or surgery
Also called ESPB
Investigators will perform the lumbar ESPB under ultrasound control at the L3 level on the ipsilateral site of the surgery. After dissection with 0.9 NaCl, we will leave a catheter in the ESP. Then, we used 0.25% bupivacaine with epinephrine (5mcg/mL), 0.4 mL per kg, up to 40 mL.
Epidural analgesiaProcedure or surgery
After identifying the epidural space and spinal anesthesia (combined technique), a catheter will be placed in the epidural space. Investigators will give an epidural catheter a test dose of 2% lidocaine (2 mL). At the end of the surgery, the patient will receive 5 mL of a mixture containing 0.1% bupivacaine with fentanyl (2 mcg/mL).
patient-controlled analgesiaProcedure or surgery
Also called PCA
Each participant will receive a pump with oxycodone (1mg/ml) using a patient-controlled analgesia (PCA) technique, a bolus of 1 mL, and a lockout of 5 minutes for the first postoperative day.
Timed Up and Go testDiagnostic test
Also called TUG
Investigators will measure the time the patient took to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while rotating 180 degrees. We will assess the patient before the surgery and 24 and 48 hours after hip replacement.
neuropathic pain symptom inventoryDiagnostic test
Also called NPSI
The Neuropathic Pain Symptom Inventory (0-100; 0 denotes no pain, 100 the most severe pain) will be evaluated before the surgery and three and six months following the procedure.
Lovett testDiagnostic test
A physiotherapist will use the six-grade Lovett scale to measure muscle strength, in which 0 denotes no muscle contractility, and 5 denotes the complete range of motion against gravity, with full resistance. We will test this before the surgery, 24 and 48 hours after the operation.
Visual analog scaleDiagnostic test
Also called VAS
Investigators will measure pain intensity with VAS (0-10; 0 denotes no pain, 10 maximal pain) before and after the surgery. Pain will be evaluated at rest and upon the activity.
Quality of Recovery 40Diagnostic test
Also called QoR-40
Investigators will assess the quality of recovery with QoR-40 a day after the surgery, a month, and three months following the procedure. The minimal score is 40, and the maximal is 200. The higher the result, the better the quality of recovery is.
Ability to sit, stand upright, and walkDiagnostic test
A physiotherapist will evaluate the patient's ability to sit, stand upright, and walk at planned times.
| Study group | Role | What they receive |
|---|---|---|
| Epidural | Experimental | Combined spinal and epidural anesthesia will be performed before the surgery in the patient's lateral position with the operated hip down. The Espocan set will be used (B.Braun). After identification of the epidural space on the level of L3/L4, 0.5% bupivacaine (Marcaine Heavy Spinal) with fentanyl (5 mcg/mL) will be injected through the 27 G pencil point spinal needle. Then, the epidural catheter will be placed and a test dose of 2% lidocaine (2 mL) will be administered. At the end of the surgery, the patient will receive 5 mL of a mixture containing 0.1% bupivacaine with fentanyl (2 mcg/mL). Moreover, we will administer 5 mg of oxycodone i.v.
the mixture of bupivacaine and fentanyl will be administered in a constant flow of 5 mL/h for a day. Receives: Procedure: Spinal anesthesia; Procedure: Epidural analgesia; Procedure: patient-controlled analgesia; Diagnostic Test: Timed Up and Go test; Diagnostic Test: neuropathic pain symptom inventory; Diagnostic Test: Lovett test; Diagnostic Test: Visual analog scale; Diagnostic Test: Quality of Recovery 40; Diagnostic Test: Ability to sit, stand upright, and walk |
| ESPB | Experimental | Spinal anesthesia will be performed in the patient's lateral position with the operated hip down. 0.5% bupivacaine (Marcaine Heavy Spinal) with fentanyl (5 mcg/mL) will be used and a 25-27 G pencil point spinal needle.
The lumbar ESPB will be performed under ultrasound control at the L3 level on the ipsilateral site of the surgery. After dissection with 0.9 NaCl, a catheter will be left in the ESP. Then, we will administer 0.25% bupivacaine with epinephrine (5mcg/mL), 0.4 mL per kg, up to 40 mL. Moreover, 5 mg of oxycodone i.v. will be administered A mixture of 0.1% bupivacaine with fentanyl (2 mcg/mL) will be given in a constant flow of 5 mL/h for a day. Receives: Procedure: Spinal anesthesia; Procedure: lumbar erector spinae plane block; Procedure: patient-controlled analgesia; Diagnostic Test: Timed Up and Go test; Diagnostic Test: neuropathic pain symptom inventory; Diagnostic Test: Lovett test; Diagnostic Test: Visual analog scale; Diagnostic Test: Quality of Recovery 40; Diagnostic Test: Ability to sit, stand upright, and walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiod consumtion with PCA
Oxycodone consumtion used with a patient-controlled analgesia pump
Measured: From the admission to the postoperative care unit to the next postoperative day for 24 hours.
Secondary outcomes (6)
Pain at rest
Pain measured at rest on the VAS (0-10)
Measured: 24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation
Pain upon activity
Pain measured upon activity on the VAS (0-10)
Measured: 24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation
Lovett test
The quadriceps femori's muscle strength on the Lovett scale (0-5)
Measured: 24 hours before the surgery, 24 and 48 hours after the operation
TUG
Timed Up and Go test in seconds
Measured: 24 hours before the surgery, 24 and 48 hours after the operation
QoR-40
quality of recovery 40
Measured: It will be measured 24 hours, 30 days, and three months following the surgery.
NPSI
The Neuropathic Pain Symptom Inventory will be measured personally and after the discharge with a phone interview.
Measured: 24 hours before the surgery and 3 and 6 months following the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start19 Feb 2024
- Primary completion1 Feb 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoxarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will be randomly allocated to Epidural and ESPB (1:1)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Borys, Medical University of Lublin
- Investigators
- Paweł Piwowarczyk, M.D., Ph.D., Study chair, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282666
- Sponsor's protocol ID
- KE-0254/150/2019
- Acronym
- ESPB_HIP
- Status last verified
- Jul 2024
- First submitted
- 12 Feb 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanych A, Kutnik P, Pasiak P, Zakrzewska-Szalak A, Wichowska O, Jednakiewicz M, Nogalski A, Piwowarczyk P, Borys M. Continuous lumbar erector spinae plane block as an alternative to epidural analgesia in pain treatment in patients undergoing hip replacement surgery - a prospective pilot study. Anaesthesiol Intensive Ther. 2023;55(4):272-276. doi: 10.5114/ait.2023.132517.
PubMed 38084571
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continuous Lumbar Erector Spinae Plane Block to Continuous Epidural Analgesia in Patients Undergoing Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT06282666
- Acronym / sponsor ID
- ESPB_HIP / KE-0254/150/2019
- Conditions
- Coxarthrosis, Pain, Postoperative, Pain, Acute, Pain, Chronic, Postoperative Pain, Chronic, Analgesia
- Keywords
- erector spinae plane block, epidural analgesia, quality of recovery, patient-controlled analgesia, Timed Up and Go test, visual analog scale, neuropathic pain symptom inventory, Lovett scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed.
Detailed description
This is a prospective trial in patients undergoing elective hip replacement surgery.
Written informed consent will be obtained from each patient, and our study will be conducted following the tenets of the Declaration of Helsinki for medical research involving human subjects.
Before the surgery, preoperative pain severity, chronic pain severity, and ability to sit, stand, and walk will be assessed.
Each participant will be anesthetized with spinal technique and randomly allocated patients according to postoperative analgesia to the continuous epidural (Epidural) group and the continuous lumbar erector spinae plane block (ESPB) group. Both regional techniques will be continued during the first day. Investigators will measure postoperative oxycodone consumption with a patient-controlled analgesia (PCA) pump. At several points, the patients' pain at rest and during activity will be evaluated on the visual analog scale (VAS, 0-10), their quadriceps femoris muscle strength on the Lovett scale (0-5), and their ability to sit, stand upright, and walk on the Timed Up and Go test. Moreover, the patient's recovery will be assessed through the Quality of Recovery 40 (QoR-40) questionnaire on the first postoperative day.
After the patient's discharge, information regarding acute and chronic pain severity and quality of recovery will be collected during the phone interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups will be randomly allocated to Epidural and ESPB (1:1)
| Arm | Type | Receives |
|---|---|---|
| Epidural | Experimental | Procedure: Spinal anesthesia, Procedure: Epidural analgesia, Procedure: patient-controlled analgesia, Diagnostic Test: Timed Up and Go test, Diagnostic Test: neuropathic pain symptom inventory, Diagnostic Test: Lovett test, Diagnostic Test: Visual analog scale, Diagnostic Test: Quality of Recovery 40, Diagnostic Test: Ability to sit, stand upright, and walkCombined spinal and epidural anesthesia will be performed before the surgery in the patient's lateral position with the operated hip down. The Espocan set will be used (B.Braun). After identification of the epidural space on the level of L3/L4, 0.5% bupivacaine (Marcaine Heavy Spinal) with fentanyl (5 mcg/mL) will be injected through the 27 G pencil point spinal needle. Then, the epidural catheter will be placed and a test dose of 2% lidocaine (2 mL) will be administered. At the end of the surgery, the patient will receive 5 mL of a mixture containing 0.1% bupivacaine with fentanyl (2 mcg/mL). Moreover, we will administer 5 mg of oxycodone i.v. the mixture of bupivacaine and fentanyl will be administered in a constant flow of 5 mL/h for a day. |
| ESPB | Experimental | Procedure: Spinal anesthesia, Procedure: lumbar erector spinae plane block, Procedure: patient-controlled analgesia, Diagnostic Test: Timed Up and Go test, Diagnostic Test: neuropathic pain symptom inventory, Diagnostic Test: Lovett test, Diagnostic Test: Visual analog scale, Diagnostic Test: Quality of Recovery 40, Diagnostic Test: Ability to sit, stand upright, and walkSpinal anesthesia will be performed in the patient's lateral position with the operated hip down. 0.5% bupivacaine (Marcaine Heavy Spinal) with fentanyl (5 mcg/mL) will be used and a 25-27 G pencil point spinal needle. The lumbar ESPB will be performed under ultrasound control at the L3 level on the ipsilateral site of the surgery. After dissection with 0.9 NaCl, a catheter will be left in the ESP. Then, we will administer 0.25% bupivacaine with epinephrine (5mcg/mL), 0.4 mL per kg, up to 40 mL. Moreover, 5 mg of oxycodone i.v. will be administered A mixture of 0.1% bupivacaine with fentanyl (2 mcg/mL) will be given in a constant flow of 5 mL/h for a day. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary hip replacement surgery due to coxarthrosis
- anesthetized with spinal technique
- able to use PCA pump
- having access to phone
Key exclusion criteria (6 listed)
- patients taking painkillers not related to coxarthrosis;
- having active cancer,
- dementia or challenging contact with the patient;
- suffering from depression or other psychiatric disorders that required antidepressant treatment;
- consuming alcohol or recreational drug addiction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesiaAlso: Subarachnoid anesthesiaBefore the beginning of surgery, all patients will be anesthetized with 0.5 % hyperbaric bupivacaine (Marcaine Heavy), 1.5 - 2.5 mL solution. A pencil point spinal needle will be used. | Procedure or surgery | ESPB, Epidural |
| lumbar erector spinae plane blockAlso: ESPBInvestigators will perform the lumbar ESPB under ultrasound control at the L3 level on the ipsilateral site of the surgery. After dissection with 0.9 NaCl, we will leave a catheter in the ESP. Then, we used 0.25% bupivacaine with epinephrine (5mcg/mL), 0.4 mL per kg, up to 40 mL. | Procedure or surgery | ESPB |
| Epidural analgesiaAfter identifying the epidural space and spinal anesthesia (combined technique), a catheter will be placed in the epidural space. Investigators will give an epidural catheter a test dose of 2% lidocaine (2 mL). At the end of the surgery, the patient will receive 5 mL of a mixture containing 0.1% bupivacaine with fentanyl (2 mcg/mL). | Procedure or surgery | Epidural |
| patient-controlled analgesiaAlso: PCAEach participant will receive a pump with oxycodone (1mg/ml) using a patient-controlled analgesia (PCA) technique, a bolus of 1 mL, and a lockout of 5 minutes for the first postoperative day. | Procedure or surgery | ESPB, Epidural |
| Timed Up and Go testAlso: TUGInvestigators will measure the time the patient took to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while rotating 180 degrees. We will assess the patient before the surgery and 24 and 48 hours after hip replacement. | Diagnostic test | ESPB, Epidural |
| neuropathic pain symptom inventoryAlso: NPSIThe Neuropathic Pain Symptom Inventory (0-100; 0 denotes no pain, 100 the most severe pain) will be evaluated before the surgery and three and six months following the procedure. | Diagnostic test | ESPB, Epidural |
| Lovett testA physiotherapist will use the six-grade Lovett scale to measure muscle strength, in which 0 denotes no muscle contractility, and 5 denotes the complete range of motion against gravity, with full resistance. We will test this before the surgery, 24 and 48 hours after the operation. | Diagnostic test | ESPB, Epidural |
| Visual analog scaleAlso: VASInvestigators will measure pain intensity with VAS (0-10; 0 denotes no pain, 10 maximal pain) before and after the surgery. Pain will be evaluated at rest and upon the activity. | Diagnostic test | ESPB, Epidural |
| Quality of Recovery 40Also: QoR-40Investigators will assess the quality of recovery with QoR-40 a day after the surgery, a month, and three months following the procedure. The minimal score is 40, and the maximal is 200. The higher the result, the better the quality of recovery is. | Diagnostic test | ESPB, Epidural |
| Ability to sit, stand upright, and walkA physiotherapist will evaluate the patient's ability to sit, stand upright, and walk at planned times. | Diagnostic test | ESPB, Epidural |
Primary outcome
Opiod consumtion with PCA
Time frame: From the admission to the postoperative care unit to the next postoperative day for 24 hours.
Oxycodone consumtion used with a patient-controlled analgesia pump
6 secondary outcomes
Pain at rest
Time frame: 24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation
Pain upon activity
Time frame: 24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation
Lovett test
Time frame: 24 hours before the surgery, 24 and 48 hours after the operation
TUG
Time frame: 24 hours before the surgery, 24 and 48 hours after the operation
QoR-40
Time frame: It will be measured 24 hours, 30 days, and three months following the surgery.
NPSI
Time frame: 24 hours before the surgery and 3 and 6 months following the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 38084571Hanych A, Kutnik P, Pasiak P, Zakrzewska-Szalak A, Wichowska O, Jednakiewicz M, Nogalski A, Piwowarczyk P, Borys M. Continuous lumbar erector spinae plane block as an alternative to epidural analgesia in pain treatment in patients undergoing hip replacement surgery - a prospective pilot study. Anaesthesiol Intensive Ther. 2023;55(4):272-276. doi: 10.5114/ait.2023.132517.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Piwowarczyk, M.D., Ph.D. study chair
Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia, lumbar erector spinae plane block and Epidural analgesia in people with Coxarthrosis and Pain, Postoperative, run by Medical University of Lublin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opiod consumtion with PCA (time frame: From the admission to the postoperative care unit to the next postoperative day for 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06282666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.